Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2877-2018Class II

Ulnar Osteotomy Compression Plate, Short Model: UOCP-S

Trimed Inc / initiated 2018-04-16 / Terminated / root cause: manufacturing process

TriMed Inc. began a recall of Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical... on . FDA classified it as Class II and gives the reason as "Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2877-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Trimed Inc
Product
Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
Product code
HRS Plate, Fixation, Bone
Reason for recall
Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Tri-Med issued notification on April 16, 2018 requesting: Determine the lot number of all Ulnar Osteotomy Compression Plates, Short (UOCP-S) .If you have UOCP-S plates with the lot numbers listed (10003, 10017): o Remove the UOCP-S plates from the tray and quarantine it. Do not use this plate. Contact TriMed at [email protected] or call 800-633-7221. TriMed will arrange have the plate(s) returned to the company and replaced. Return the Recall Response card attached to this letter to TriMed as soon as possible. Contact TriMed via telephone or email as per below if you have any questions: Telephone*: 800-633-7221, Email: [email protected]. TriMed will replace the potentially defective plates with plates that have been manufactured and confirmed to meet TriMeds specifications.
Quantity in commerce
722
Distribution
Worldwide Distribution in the state of TX and countries of Australia, China Sweden
Product codes and lots
Lot Numbers: 10003, 10017

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2877-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2877-2018Class IITerminatedVoluntary: Firm initiated